Postintensive Care SyndromeNCT05137977
Is Invasive ICU-treatment Associated With Mental Illness?
An observational study of Postintensive Care Syndrome and Anxiety Disorder, run by Uppsala University.
Trial summary
Understanding long-term complications after intensive care is important to be able to offer prophylactic and therapeutic measures to post-intensive care unit (ICU) patients. Since patients in the ICU experience life threatening conditions, severe psychological and physical stress, we hypothesized that patients after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postintensive Care Syndrome, Anxiety Disorder, Depression
- What is being tested?
- Intensive Care
- Type of treatment
- Surgery or procedure
- How many people
- 1,048,576 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 2015
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Nationwide registry of patients admitted to ICU treatment in Sweden.
Who may be able to join
- 18 years old
Who cannot join
- ICD codes for previous mental illness.
- ICU stay less than 24 hours
About this study
Understanding long-term complications after intensive care is important to be able to offer prophylactic and therapeutic measures to post-intensive care unit (ICU) patients.
Since patients in the ICU experience life threatening conditions, severe psychological and physical stress, we hypothesized that patients after ICU have an increased risk of mental illnesses specifically anxiety disorders, depression and post-traumatic stress disorder (PTSD). Moreover, we hypothesized that the prevalence and severity of mental illnesses are related to the extent of intensive care.
Read more
Our endpoints are the prevalence of anxiety disorders, depression one year after ICU-care and if the extent of intensive care an independent predictor of psychiatric illness one year after ICU admission.
We will assess Swedish Intensive Care registry data for all adult ICU patients admitted between 2010-2015 and assess ICD-10 codes for anxiety disorders, depression and PTSD one year after ICU admission.
Read the detailed description
Background
As intensive care unit (ICU)-mortality rates are improving in many areas, research focus has turned towards sequelae after ICU-care. The term Post Intensive Care Syndrome has been coined, concluding a high frequency of mental illness, cognitive and physical impairment immediately after ICU-care. Since patients in the ICU experience life threatening conditions, severe psychological and physical stress, we hypothesize that patients after ICU have an increased risk of long-term mental illnesses that increase with the extent of intensive care, specifically anxiety, and post-traumatic stress disorder (PTSD). Current data on the extent and severity of mental illness after intensive care, and if intensive care is an independent predictor of it, is limited.
Objective
Our objective is to assess in nationwide data if extensive ICU-treatment contributes to mental illness. Extensive ICU-treatment will be defined in our dataset as ICU-treatment of patients in need of invasive ventilation, and/or continuous renal replacement therapy (CRRT). Our endpoints are prevalence of mental illness one year after discharge, and its association between extent of ICU-treatment.
Method
We will use the Swedish intensive Care registry of intensive care patients treated between 2010 and 2015 for extracting data on Data on Invasive ventilation treatment, CRRT-treatment, gender and age. ICD-10 codes corresponding for anxiety, PTSD and depression, and other diagnoses known to increase the risk of mental illness will be extracted from the Swedish National Patient Registry. Patients younger than 18 years old and ICU-codes corresponding for pre-existing anxiety, PTSD, depression, and treatment periods less than 24 hours will be excluded from the study. Missing data will be imputed. A multivariable regression model will be fit using ICU-codes corresponding with mental illness as dependent variable, Invasive ventilation and CRRT as independent variables, and the other parameters as covariates.
- Conditions
- Postintensive Care Syndrome, Anxiety Disorder, Depression, PTSD, PICS, Intensive Care Psychiatric Disorder
- Being tested
- Intensive Care
- Medical subject headings
- postintensive care syndrome, Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive CareProcedure or surgery
Also called CRRT, Invasive ventilation
Invasive ventilation more than 24hs.
| Study group | Role | What they receive |
|---|---|---|
| SIR | All adult intensive care patients. Data from the The Swedish intensive care registry Receives: Procedure: Intensive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental illness
Defined as PTSD, depressive symptoms or anxiety or combination of the earlier mentioned.
Measured: 2010-2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start1 Jan 2010
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postintensive Care SyndromeStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 1,048,576 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137977
- Sponsor's protocol ID
- RBM2021
- Status last verified
- Nov 2021
- First submitted
- 16 Nov 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Invasive ICU-treatment Associated With Mental Illness?
- ClinicalTrials.gov ID
- NCT05137977
- Acronym / sponsor ID
- RBM2021
- Conditions
- Postintensive Care Syndrome, Anxiety Disorder, Depression, PTSD, PICS, Intensive Care Psychiatric Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,048,576 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Understanding long-term complications after intensive care is important to be able to offer prophylactic and therapeutic measures to post-intensive care unit (ICU) patients.
Since patients in the ICU experience life threatening conditions, severe psychological and physical stress, we hypothesized that patients after ICU have an increased risk of mental illnesses specifically anxiety disorders, depression and post-traumatic stress disorder (PTSD). Moreover, we hypothesized that the prevalence and severity of mental illnesses are related to the extent of intensive care.
Our endpoints are the prevalence of anxiety disorders, depression one year after ICU-care and if the extent of intensive care an independent predictor of psychiatric illness one year after ICU admission.
We will assess Swedish Intensive Care registry data for all adult ICU patients admitted between 2010-2015 and assess ICD-10 codes for anxiety disorders, depression and PTSD one year after ICU admission.
Detailed description
Background
As intensive care unit (ICU)-mortality rates are improving in many areas, research focus has turned towards sequelae after ICU-care. The term Post Intensive Care Syndrome has been coined, concluding a high frequency of mental illness, cognitive and physical impairment immediately after ICU-care. Since patients in the ICU experience life threatening conditions, severe psychological and physical stress, we hypothesize that patients after ICU have an increased risk of long-term mental illnesses that increase with the extent of intensive care, specifically anxiety, and post-traumatic stress disorder (PTSD). Current data on the extent and severity of mental illness after intensive care, and if intensive care is an independent predictor of it, is limited.
Objective
Our objective is to assess in nationwide data if extensive ICU-treatment contributes to mental illness. Extensive ICU-treatment will be defined in our dataset as ICU-treatment of patients in need of invasive ventilation, and/or continuous renal replacement therapy (CRRT). Our endpoints are prevalence of mental illness one year after discharge, and its association between extent of ICU-treatment.
Method
We will use the Swedish intensive Care registry of intensive care patients treated between 2010 and 2015 for extracting data on Data on Invasive ventilation treatment, CRRT-treatment, gender and age. ICD-10 codes corresponding for anxiety, PTSD and depression, and other diagnoses known to increase the risk of mental illness will be extracted from the Swedish National Patient Registry. Patients younger than 18 years old and ICU-codes corresponding for pre-existing anxiety, PTSD, depression, and treatment periods less than 24 hours will be excluded from the study. Missing data will be imputed. A multivariable regression model will be fit using ICU-codes corresponding with mental illness as dependent variable, Invasive ventilation and CRRT as independent variables, and the other parameters as covariates.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIR | – | Procedure: Intensive CareAll adult intensive care patients. Data from the The Swedish intensive care registry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Nationwide registry of patients admitted to ICU treatment in Sweden.
Key inclusion criteria (1 listed)
- 18 years old
Key exclusion criteria (2 listed)
- ICD codes for previous mental illness.
- ICU stay less than 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive CareAlso: CRRT, Invasive ventilationInvasive ventilation more than 24hs. | Procedure or surgery | SIR |
Primary outcome
Mental illness
Time frame: 2010-2015
Defined as PTSD, depressive symptoms or anxiety or combination of the earlier mentioned.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
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PICS-p Longitudinal Cohort Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Postintensive Care Syndrome and Anxiety Disorder, run by Uppsala University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental illness (time frame: 2010-2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.